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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 14-516
Standard
ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
Scope/Abstract
1.1 Method A of this test method defines a procedure that will detect and locate a leak equal to or greater than a channel formed by a 50 µm [0.002 in.] wire in the edge seals of a nonporous package. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a minimum specified time, the package is visually inspected for dye penetration or, preferably, the seal edge is placed against an absorbent surface and the surface inspected for staining from the dye.

1.2 Method B for this test method also defines a procedure that will detect and locate a leak equal to or greater than 10 µm [0.00039 in] diameter in a nonporous flat sheet. The flat sheet is placed on an absorbent surface and then a dye penetrant is spread across the surface of the sheet, preferably using a small roller to apply pressure on the sheet to ensure adequate contact between the absorbent surface and the bottom surface of the sample being tested. The flat sheet is carefully removed and the absorbent surface is inspected for staining from the dye.

1.3 These test methods are used for both transparent and opaque nonporous surfaces.

1.4 These test methods require that the dye penetrant have good contrast to the materials being tested and/or the absorbent surface.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
FDA Technical Contact
 Patrick Weixel
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/
  301-796-5537
  Patrick.Weixel@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Sterility
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